Fast MR for Young Children With Traumatic Brain Injury

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: TBI (Traumatic Brain Injury)

Treatments: Procedure: Computed Tomography; Procedure: Fast MR

Study type: Interventional

Funder types: Other

Identifiers

NCT02392975

14-1917

Details and patient eligibility

About

This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI).

In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disability and death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations.

Fast MR is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR has not been validated in children with TBI, a critical gap. The investigators will measure feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old who undergo head CT for TBI.

The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared to determine: 1) whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR without sedation can be performed quickly and successfully.

Enrollment: 225 patients

Sex: All

Ages: Under 72 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children <72 months old in whom a head CT is ordered/obtained with concerns for TBI
• Present to the Children's Hospital Colorado (CHCO) Emergency Department (ED) or inpatient wards

Exclusion criteria

• Contraindication to MR (e.g. pacemaker, implanted metallic object incompatible with MR)
• Prior diagnosis of TBI, structural brain lesion or prior brain surgery including shunted hydrocephalus
• Prior participation in this study
• Clinically unstable in the opinion of the patient's attending physician
• Wards of the State
• TBI not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 1 patient group

Fast magnetic resonance imaging (Fast MR)

Experimental group

Description:

All subjects will undergo fast MR in addition to Computerized Tomography (CT) (the current criterion standard). Fast MR will be interpreted independently for research purposes by 2 blinded radiologists. Consensus interpretation will be compared to the clinical reading of the CT.

Treatment:

Procedure: Computed Tomography

Procedure: Fast MR